Systems and methods for internal drug loading for infusion processes

Abstract

Methods for applying a therapeutic agent coating to an extended-wear device and the systems created thereby are disclosed. For example, a method for coating an extended-wear device using N-TIPS provides therapeutic agent coating for localized treatment in a patient using an extended-wear device for monitoring or treatment of illness or injury, wherein such methods can be used on polymeric films or within polymeric tubes.

What is claimed is: 
     
         1 . A method of coating a medical device with a therapeutic agent, the method comprising:
 introducing a solution comprising the therapeutic agent to a surface of the medical device;   freezing the medical device with the solution so that the therapeutic agent precipitates from the solution; and   washing the medical device with a non-solvent, wherein the precipitated therapeutic agent remains as a coating on the surface of the medical device.   
     
     
         2 . The method of  claim 1 , wherein the surface is an inner surface of an inner lumen of a line set tubing. 
     
     
         3 . The method of  claim 2 , wherein the line set tubing is a component of an infusion device. 
     
     
         4 . The method of  claim 1 , wherein the surface is an inner surface of an inner lumen of a catheter. 
     
     
         5 . The method of  claim 1 , wherein the surface is a surface of a film. 
     
     
         6 . The method of  claim 1 , wherein the surface is a polymeric surface. 
     
     
         7 . The method of  claim 6 , wherein the surface comprises low-density polyethylene. 
     
     
         8 . The method of  claim 1 , further comprising the step of pretreating the surface of the medical device with at least one of a heated pretreatment or a plasma-etching pretreatment before introducing the solution comprising the therapeutic agent to the surface. 
     
     
         9 . The method of  claim 1 , further comprising the step of heating the medical device with the solution to a temperature of about 80° C. after introducing the solution to the surface. 
     
     
         10 . The method of  claim 1 , wherein during the freezing step, the therapeutic agent crystallizes on the surface. 
     
     
         11 . The method of  claim 1 , wherein only the therapeutic agent precipitates. 
     
     
         12 . The method of  claim 11 , wherein the therapeutic agent is water-insoluble. 
     
     
         13 . The method of  claim 1 , wherein the therapeutic agent is meloxicam. 
     
     
         14 . The method of  claim 1 , wherein a matrix comprising the therapeutic agent and a polymer precipitates. 
     
     
         15 . The method of  claim 14 , wherein the therapeutic agent is water-soluble. 
     
     
         16 . An infusion device for extended wear, the infusion device comprising:
 a base;   an adhesive configured to couple the base to a skin of a patient; and   a catheter configured to pierce the skin of the patient, wherein the catheter is in fluid communication with a tubing including a therapeutic coating on an inner surface of an inner lumen defined by the tubing, the therapeutic coating disposed on the inner surface of the inner lumen defined by the tubing using N-TIPS.   
     
     
         17 . The infusion device of  claim 16 , wherein the therapeutic coating consists essentially of a therapeutic agent. 
     
     
         18 . The infusion device of  claim 17 , wherein the therapeutic agent is meloxicam. 
     
     
         19 . The infusion device of  claim 16 , wherein the catheter is configured to remain inserted in the patient for 14 days, and wherein the therapeutic coating is configured to continuously release the therapeutic agent while the catheter is inserted. 
     
     
         20 . The infusion device of  claim 16 , wherein the therapeutic agent is in a crystalline form. 
     
     
         21 . The infusion device of  claim 16 , wherein the tubing is comprised of low-density polyethylene.